The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use have brought some good news for Novartis, GlaxoSmithKline and Teva.
First up, the CHMP has recommended approval of Novartis’ antihypertensive Rasilamlo, which combines the Swiss drugmaker’s Rasilez (aliskiren; sold as Tekturna in the USA) and the long-acting calcium channel blocker amlodipine. The combo is for adults whose blood pressure is not adequately controlled with either of the drugs when used alone.
The committee also adopted a positive opinion recommending the granting of marketing authorisation for Sprimeo HCT (aliskiren/hydrochlorothiazide) and backed generic versions of Roche/GlaxoSmithKline’s Bondronat (ibandronic acid) made by Novartis’ Sandoz and Hexal units for the prevention of skeletal events in patients with breast cancer and bone metastases.
The CHMP has also recommended approval of Hizentra (human normal immunoglobulin), from CSL Behring for replacement therapy in people with primary immunodeficiency syndromes, and in myeloma or chronic lymphatic leukaemia patients with severe secondary hypogammaglobulinaemia and recurrent infections. There was also backing for Provepharm of France’s Proveblue (methylthioninium) for acute symptomatic treatment of methaemoglobinaemia.
With regards to GSK, the CHMP said it has reviewed further data from Finland on the UK drug giant’s swine flu vaccine Pandemrix, which “added to the concern arising from case reports in Finland and Sweden” concerning a link with narcolepsy. The committee has concluded that the evidence is “still insufficient to establish a causal relationship”, a stance it took following its September 2010 meeting.
The committee has also completed an arbitration procedure initiated by the Netherlands because of disagreement among EU member states regarding the authorisation of Teva’s generic version of Sanofi-Aventis’ chemotherapy Taxotere (docetaxel). There had been concerns that bioequivalence studies had not been performed, but the CHMP concluded that additional data was not needed and that the benefit-risk balance of this medicine is positive. It has recommended that marketing authorisations should be granted in the Netherlands as well as in all European states.
Also of note from this latest meeting were the decisions to recommend an extension on Abbott Laboratories’ blockbuster Humira (adalimumab) to include treatment of juvenile idiopathic arthritis in patients aged 4 to 12 and amend the label on Pfizer’s Tygacil (tigecycline) to make prescribers aware that “the medicine has been associated with an increased mortality in clinical studies”. The latter should only be used for complicated skin, soft tissue intra-abdominal infections, “and only when other antibiotics are not suitable”.
The CHMP concluded by noting a manufacturing problem Johnson & Johnson has had prefilled pens of Simponi (golimumab) pre-filled pens for the treatment of rheumatoid and psoriatic arthritis, as well as ankylosing spondylitis. This will lead to a temporary shortage in some EU countries and patients should be switched to the prefilled Simponi syringe or to alternative treatments.
